艾司氯胺酮不同给药方式对术后痛觉过敏的影响

注册号:

Registration number:

ChiCTR2400083196 

最近更新日期:

Date of Last Refreshed on:

2024-04-18 08:11:01 

注册时间:

Date of Registration:

2024-04-18 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

艾司氯胺酮不同给药方式对术后痛觉过敏的影响

Public title:

The effect of different administration methods of ketamine on postoperative pain hypersensitivity

注册题目简写:

艾司氯胺酮不同给药方式对术后痛觉过敏的影响

English Acronym:

The effect of different administration methods of ketamine on postoperative pain hypersensitivity

研究课题的正式科学名称:

艾司氯胺酮不同给药方式对术后痛觉过敏的影响

Scientific title:

The effect of different administration methods of ketamine on postoperative pain hypersensitivity

研究课题代号(代码):

Study subject ID:

2023GLLH0451

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

46063143615220111A1001

申请注册联系人:

马玉华 

研究负责人:

马玉华 

Applicant:

Ma Yuhua 

Study leader:

Ma Yuhua 

申请注册联系人电话:

Applicant telephone:

+86 138 4793 0665

研究负责人电话:

Study leader's
telephone:

+86 138 4793 0665

申请注册联系人传真 :

Applicant Fax:

0482-8411680

研究负责人传真:

Study leader's fax:

0482-8411680

申请注册联系人电子邮件:

Applicant E-mail:

3221410993@qq.com

研究负责人电子邮件:

Study leader's E-mail:

3221410993@qq.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

内蒙古自治区兴安盟乌兰浩特市罕山西街66号

研究负责人通讯地址:

内蒙古自治区兴安盟乌兰浩特市罕山西街66号

Applicant address:

No.66 Hanshan West Street, Ulanhot, Xing 'an League, Inner Mongolia Autonomous Region

Study leader's address:

No.66 Hanshan West Street, Ulanhot, Xing 'an League, Inner Mongolia Autonomous Region

申请注册联系人邮政编码:

Applicant postcode:

137400

研究负责人邮政编码:

Study leader's postcode:

137400

申请人所在单位:

兴安盟人民医院

Applicant's institution:

Xing 'an League People's Hospital

研究负责人所在单位:

兴安盟人民医院

Affiliation of the Leader:

Xing 'an League People's Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2023GLLH0451

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

兴安盟人民医院伦理委员会

Name of the ethic committee:

Ethics Committee of Xing 'an League People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024-01-05 00:00:00

伦理委员会联系人:

于洋

Contact Name of the ethic committee:

yuyang

伦理委员会联系地址:

内蒙古自治区兴安盟乌兰浩特市罕山西街66号

Contact Address of the ethic committee:

No.66 Hanshan West Street, Ulanhot, Xing 'an League, Inner Mongolia Autonomous Region

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 482 841 3799

伦理委员会联系人邮箱:

Contact email of the ethic committee:

mayuhua0665@163.com

研究实施负责(组长)单位:

兴安盟人民医院

Primary sponsor:

Xing 'an League People's Hospital

研究实施负责(组长)单位地址:

内蒙古自治区兴安盟乌兰浩特市罕山西街66号

Primary sponsor's address:

No.66 Hanshan West Street, Ulanhot, Xing 'an League, Inner Mongolia Autonomous Region

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

内蒙古自治区

市(区县):

乌兰浩特

Country:

China

Province:

Inner Mongolia Autonomous Region

City:

Ulanhot

单位(医院):

兴安盟人民医院

具体地址:

内蒙古自治区兴安盟乌兰浩特市罕山西街66号

Institution
hospital:

Xing 'an League People's Hospital

Address:

No.66 Hanshan West Street, Ulanhot, Xing 'an League, Inner Mongolia Autonomous Region

经费或物资来源:

内蒙古自治区医学科学院公立医院科研联合基金项目

Source(s) of funding:

Joint scientific research fund project of public hospitals of Inner Mongolia Academy of Medical Sciences

研究疾病:

胃癌、结肠癌、直肠癌  

Target disease:

Gastric cancer, colon cancer and rectal cancer

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

探索性研究/预试验 

Study phase:

0

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

通过随机、双盲、对照研究,探讨艾司氯胺酮不同给药方式对腹腔镜下胃肠道手术后痛觉过敏的影响,降低阿片类相关不良反应的发生,为腹腔镜下胃肠道手术患者快速康复提供有利条件。  

Objectives of Study:

Through a randomized, double-blind, controlled study, this paper discusses the effects of different administration methods of estaketamine on hyperalgesia after laparoscopic gastrointestinal surgery, reduces the occurrence of opioid-related adverse reactions, and provides favorable conditions for patients undergoing laparoscopic gastrointestinal surgery to recover quickly.

药物成份或治疗方案详述:

K1组:K2组:S组: 咪达唑仑2mg 咪达唑仑2mg 咪达唑仑2mg 丙泊酚2mg/kg 丙泊酚2mg/kg 丙泊酚2mg/kg 顺式阿曲库铵0.15mg/kg 顺式阿曲库铵0.15mg/kg 顺式阿曲库铵0.15mg/kg 舒芬太尼0.2ug/kg 舒芬太尼0.2ug/kg 舒芬太尼0.2ug/kg 艾司氯胺酮(10mg/ml)(体重/40)ml 艾司氯胺酮(10mg/ml) (体重/40)ml 生理盐水 (体重/40)ml 术中麻醉维持方案 K1组: 手术开始给予舒芬太尼0.1ug/kg次iv 丙泊酚5mg/kg/h(术毕停药) 间断给予顺式阿曲库铵0.03mg/kg次 艾司氯胺酮(1mg/ml)(0.2*体重)ml/h持续泵入(术毕停药) 瑞芬太尼6ug/kg.h(根据术中心率血压调整--维持基础血压±30%,调整幅度1ug/kg.h)(术毕停药) 间断给予舒芬太尼0.1ug/kg(瑞芬太尼用量大于9ug/kg.h且血压高于基础血压的30%时) 术毕给予NSAIDS药物(酮铬酸30mg) K2组: 手术开始给予舒芬太尼0.1ug/kg次iv 丙泊酚5mg/kg/h(术毕停药) 间断给予顺式阿曲库铵0.03mg/kg次 生理盐水 (0.2*体重)ml/h持续泵入 瑞芬太尼6ug/kg.h(根据术中心率血压调整--维持基础血压±30%,调整幅度1ug/kg.h)(术毕停药) 间断给予舒芬太尼0.1ug/kg(瑞芬太尼用量大于9ug/kg.h且血压高于基础血压的30%时) 术毕前20分钟给予艾司氯胺酮(10mg/ml) (体重/50)ml 术毕给予NSAIDS药物(酮铬酸30mg) S组: 手术开始给予舒芬太尼0.1ug/kg次iv 丙泊酚5mg/kg.h(术毕停药) 间断给予顺式阿曲库铵0.03mg/kg次 生理盐水 (0.2*体重)ml/h持续泵入 瑞芬太尼6ug/kg.h(根据术中心率血压调整--维持基础血压±30%,调整幅度1ug/kg.h)(术毕停药) 间断给予舒芬太尼0.1ug/kg(瑞芬太尼用量大于9ug/kg.h且血压高于基础血压的30%时) 术毕给予NSAIDS药物(酮铬酸30mg) 试验药物 用药名称:盐酸艾司氯胺酮注射液 剂型:2ml;50mg 生产单位:江苏恒瑞医药股份有限公司 产品批号:221211BL 有效期:2025年12月10日 保持条件:密闭,避光,不超过30o保存 

Description for medicine or protocol of treatment in detail:

Group K1: group K2: group s: Midazolam 2mg Midazolam 2 mg Midazolam 2 mg Midazolam 2 mg Propofol 2mg/kg Propofol 2 mg/kg Propofol 2 mg/kg Cisatracurium 0.15mg/kg Cisatracurium 0.15mg/kg Cisatracurium 0.15mg/kg Cisatracurium 0.15mg/kg Sufentanil 0.2ug/kg sufentanil 0.2 ug/kg sufentanil 0.2 ug/kg Esketamine (10mg/ml) (weight /40)ml Esketamine (10mg/ml) (weight/40) ml physiological saline (weight/40) ml. Intraoperative anesthesia maintenance scheme K1 group: Sufentanil was given 0.1ug/kg iv at the beginning of the operation. Propofol 5mg/kg/h (drug withdrawal after operation) Cisatracurium was given intermittently at 0.03mg/kg. Esketamine (1mg/ml)(0.2* body weight) ml/h was pumped continuously (drug withdrawal after operation). Remifentanil 6ug/kg.h (according to the operation center rate, the blood pressure is adjusted-the basal blood pressure is maintained by 30%, and the adjustment range is 1ug/kg.h) (the drug is stopped after operation). 0.1ug/kg sufentanil was given intermittently (when the dosage of remifentanil was more than 9 ug/kg h and the blood pressure was higher than 30% of the basal blood pressure). NSAIDS (30mg ketochromic acid) were given after operation. K2 group: Sufentanil was given 0.1ug/kg iv at the beginning of the operation. Propofol 5mg/kg/h (drug withdrawal after operation) Cisatracurium was given intermittently at 0.03mg/kg. Normal saline (0.2* body weight) ml/h is pumped continuously. Remifentanil 6ug/kg.h (according to the operation center rate, the blood pressure is adjusted-the basal blood pressure is maintained by 30%, and the adjustment range is 1ug/kg.h) (the drug is stopped after operation). 0.1ug/kg sufentanil was given intermittently (when the dosage of remifentanil was more than 9 ug/kg h and the blood pressure was higher than 30% of the basal blood pressure). Esketamine (10mg/ml) (weight/50 ml) was given 20 minutes before the operation. NSAIDS (30mg ketochromic acid) were given after operation. Group s: Sufentanil was given 0.1ug/kg iv at the beginning of the operation. Propofol 5 mg/kg h (drug withdrawal after operation) Cisatracurium was given intermittently at 0.03mg/kg. Normal saline (0.2* body weight) ml/h is pumped continuously. Remifentanil 6ug/kg.h (according to the operation center rate, the blood pressure is adjusted-the basal blood pressure is maintained by 30%, and the adjustment range is 1ug/kg.h) (the drug is stopped after operation). 0.1ug/kg sufentanil was given intermittently (when the dosage of remifentanil was more than 9 ug/kg h and the blood pressure was higher than 30% of the basal blood pressure). NSAIDS (30mg ketochromic acid) were given after operation. Experimental drug Drug name: Esketamine Hydrochloride Injection Dosage form: 2ml; 50mg Manufacturer: jiangsu hengrui Pharmaceutical Co., Ltd. Product batch number: 221211BL Validity: December 10, 2025 Preservation conditions: airtight, protected from light, and stored for no more than 30o. 

纳入标准:

Inclusion criteria

排除标准:

1. 孕期女性 2. ASA 3级以上 3. 急诊手术 4. 受法律保护的成年人(在司法保护、监护或监督下),被剥夺自由的人 5. 房室传导阻滞、窦房结阻滞或心室内传导阻滞 6. 窦性心动过缓(基础心率小于60次/min) 7. 术前低血压(收缩压低于100mmHg) 8. 术前合并耳石症、梅尼埃综合征、椎动脉狭窄 9. 脑血管疾病 10. NSAIDs药物禁忌症 11. 对麻醉药物过敏 12.中转开腹者排除

Exclusion criteria:

1. Pregnant women 2. Asa level 3 or above 3. Emergency operation 4. Adults protected by law (under judicial protection, guardianship or supervision), persons deprived of their liberty. 5. Atrioventricular block, sinoatrial node block or intraventricular block 6. Sinus bradycardia (basal heart rate less than 60 beats /min) 7. Preoperative hypotension (systolic blood pressure below 100mmHg) 8. Preoperative complications included otolith, Meniere's syndrome and vertebral artery stenosis. 9.Ccerebrovascular disease 10. Contraindications of NSAIDs drugs 11. Allergic to narcotic drugs 12. Those who converted to laparotomy were excluded.

研究实施时间:

Study execute time:

From 2023-12-01 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-05-01 00:00:00 To 2025-04-30 00:00:00

干预措施:

Interventions:

组别:

艾司氯胺酮麻醉方案组(K1组)

样本量:

33

Group:

Esketamine anesthesia scheme group (K1 group)

Sample size:

干预措施:

艾司氯胺酮麻醉方案组(K1组)麻醉诱导:艾司氯胺酮 0.25mg/kg iv,麻醉维持:艾司氯胺酮 0.2mg/kg/h持续泵入(术毕停药)

干预措施代码:

Intervention:

Anesthesia induction in Esketamine anesthesia scheme group (K1 group): Esketamine 0.25mg/kg iv, and anesthesia maintenance: Esketamine 0.2mg/kg/h was continuously pumped (drug withdrawal after operation).

Intervention code:

组别:

艾司氯胺酮麻醉方案组(K2组)

样本量:

33

Group:

Esketamine anesthesia scheme group (K2 group)

Sample size:

干预措施:

艾司氯胺酮麻醉方案组(K2组)麻醉诱导:艾司氯胺酮 0.25mg/kg iv,麻醉维持是常规用药,只在术毕前20分钟单次给予艾司氯胺酮0.2mg/kg iv。

干预措施代码:

Intervention:

Anesthesia induction in Esketamine anesthesia scheme group (K2 group): Esketamine 0.25mg/kg iv, and anesthesia maintenance was routine medication, and Esketamine 0.2mg/kg iv was given only once 20 minutes before the operation.

Intervention code:

组别:

标准含阿片类药物的麻醉方案组(S组)

样本量:

33

Group:

Standard opioid-containing anesthesia regimen group (group S)

Sample size:

干预措施:

标准含阿片类药物的麻醉方案组(S组)麻醉诱导除常规用药外,给予配置好的生理盐水 0.25mg/kg iv,麻醉维持:有一组配置好的生理盐 0.2mg/kg/h持续泵入(术毕停药)。

干预措施代码:

Intervention:

The standard opioid-containing anesthesia scheme group (group S) was given 0.25 mg/kg iv saline in addition to routine medication, and anesthesia was maintained: one group was continuously pumped with 0.2 mg/kg iv saline (drug withdrawal after operation).

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

内蒙古自治区 

市(区县):

乌兰浩特 

Country:

China

Province:

Inner Mongolia Autonomous Region

City:

Ulanhot

单位(医院):

兴安盟人民医院 

单位级别:

三甲 

Institution
hospital:

Xing 'an League People's Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

记录患者术前和术后 2,6,24,48 h 手术切口旁 5cm 及前臂内侧的机械痛阈值

指标类型:

主要指标

Outcome:

The mechanical pain threshold of 5cm beside the surgical incision and the medial forearm was recorded before and 2, 6, 24 and 48 h after operation.

Type:

Primary indicator

测量时间点:

记录患者术前和术后 2,6,24,48 h

测量方法:

手术切口旁 5cm 及前臂内侧的机械痛阈值

Measure time point of outcome:

The patients were recorded before operation and at 2, 6, 24 and 48 hours after operation.

Measure method:

Mechanical pain threshold of 5cm beside surgical incision and inside forearm

指标中文名:

视觉模拟评分法(VAS)评分

指标类型:

主要指标

Outcome:

Visual analogue scale (VAS) score

Type:

Primary indicator

测量时间点:

记录患者术前和术后 2,6,24,48 h

测量方法:

视觉模拟评分法(VAS)评分表

Measure time point of outcome:

The patients were recorded before operation and at 2, 6, 24 and 48 hours after operation.

Measure method:

Visual analogue scale (VAS) scale

指标中文名:

术后 48 h 自控镇痛按压次数及术后 48 h累计使用阿片类药物的量

指标类型:

主要指标

Outcome:

The number of self-controlled analgesic compressions and the cumulative amount of opioids used 48 hours after operation

Type:

Primary indicator

测量时间点:

术后 48 h

测量方法:

累计使用阿片类药物的量

Measure time point of outcome:

48 h after operation

Measure method:

Cumulative use of opioids

指标中文名:

记录术后不良反应,包括恶心、呕吐、头晕、谵妄或定向障碍

指标类型:

主要指标

Outcome:

Postoperative adverse reactions were recorded, including nausea, vomiting, dizziness, delirium or disorientation.

Type:

Primary indicator

测量时间点:

术后 2,6,24,48 h

测量方法:

问诊

Measure time point of outcome:

2, 6, 24 and 48 h after operation.

Measure method:

interrogation

指标中文名:

术中心血管并发症发生几率(心率失常发生率,升压药应用几率,降压药物应用几率)

指标类型:

次要指标

Outcome:

Incidence rate of vascular complications in operation center (incidence rate of arrhythmia, application rate of antihypertensive drugs, application rate of antihypertensive drugs)

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

计算

Measure time point of outcome:

Finish the operation

Measure method:

calculate

指标中文名:

术中舒芬太尼用量

指标类型:

次要指标

Outcome:

Intraoperative sufentanil dosage;

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

计算

Measure time point of outcome:

Finish the operation

Measure method:

calculate

指标中文名:

术中基本情况(血压、心率、体温、BIS)

指标类型:

次要指标

Outcome:

Basic information during operation (blood pressure, heart rate, body temperature, BIS)

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

计算

Measure time point of outcome:

Finish the operation

Measure method:

calculate

指标中文名:

术中血管活性药物用量(麻黄碱、去氧肾上腺素、阿托品、乌拉地尔、艾司洛尔等)

指标类型:

次要指标

Outcome:

Dosage of vasoactive drugs during operation (ephedrine, phenylephrine, atropine, urapidil, esmolol, etc.)

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

计算

Measure time point of outcome:

Finish the operation

Measure method:

calculate

指标中文名:

术中输液量、出血量、尿量

指标类型:

次要指标

Outcome:

Intraoperative infusion volume, bleeding volume and urine volume

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

计算

Measure time point of outcome:

Finish the operation

Measure method:

calculate

指标中文名:

术中并发症(心率失常、心梗、心脏骤停、低氧血症、过敏、术中知晓等)

指标类型:

次要指标

Outcome:

Intraoperative complications (arrhythmia, myocardial infarction, cardiac arrest, hypoxemia, allergy, intraoperative awareness, etc.)

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

观察

Measure time point of outcome:

Finish the operation

Measure method:

observe

指标中文名:

停药到气管插管拔除时间

指标类型:

次要指标

Outcome:

Time from drug withdrawal to tracheal intubation removal

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

计算

Measure time point of outcome:

Finish the operation

Measure method:

calculate

指标中文名:

拔管到Aldrete大于9分的时间

指标类型:

次要指标

Outcome:

Time from extubation to Aldrete is more than 9 minutes.

Type:

Secondary indicator

测量时间点:

术毕

测量方法:

计算

Measure time point of outcome:

Finish the operation

Measure method:

calculate

指标中文名:

气管插管拔除后2h、6h、24h、48h活动和静息状态下疼痛情况(采用手术切口旁 5cm 及前臂内侧的机械痛阈值,VAS评分)

指标类型:

次要指标

Outcome:

Pain at 2h, 6h, 24h, 48h after tracheal intubation (mechanical pain threshold of 5cm beside the surgical incision and inside the forearm, VAS score)

Type:

Secondary indicator

测量时间点:

术后 2,6,24,48 h

测量方法:

观察

Measure time point of outcome:

2, 6, 24 and 48 h after operation.

Measure method:

observe

指标中文名:

术后48h阿片类药物的用量

指标类型:

次要指标

Outcome:

The dosage of opioids 48 hours after operation.

Type:

Secondary indicator

测量时间点:

术后48h

测量方法:

计算

Measure time point of outcome:

48h after operation.

Measure method:

calculate

指标中文名:

术后心血管并发症发生几率

指标类型:

次要指标

Outcome:

Incidence rate of postoperative cardiovascular complications

Type:

Secondary indicator

测量时间点:

术后48h

测量方法:

计算

Measure time point of outcome:

48h after operation.

Measure method:

calculate

指标中文名:

术后住院天数

指标类型:

次要指标

Outcome:

Postoperative hospitalization days

Type:

Secondary indicator

测量时间点:

出院

测量方法:

计算

Measure time point of outcome:

to be discharged from hospital

Measure method:

calculate

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 32 years
最大 Max age 76 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机、双盲、对照研究。患者将随机分为三组。为了确保组间的可比性,将采用随机分组。随机化将由研究者尽可能靠近手术进行。每名患者将获得一个唯一的患者编号,计算机将生成一个随机编号(患者代码)

Randomization Procedure (please state who generates the random number sequence and by what method):

Randomized, double-blind, controlled study. Patients will be randomly divided into three groups. In order to ensure comparability between groups, random grouping will be adopted. Randomization will be carried out by researchers as close as possible to the operation. Each patient will get a unique patient number, and the computer will generate a random number (patient code).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

确定患者入组后,由研究助手配制三组诱导及维持药物,麻醉医生按方案进行诱导和术中维持,术毕配制舒芬太尼镇痛泵同时由研究助手给予试验用镇痛泵。术毕返回恢复室(PACU),由PACU护士进行术后评估,术后随访由另一名研究助手完成。试验过程中只有进行配药的研究助手知道分组情况,他/她不会在任何时候参与麻醉及对患者的评估。麻醉医生、手术医生、术后随访护士、患者及病房护士均不知道分组情况

Blinding:

After the patients were confirmed to be in the group, the research assistant prepared three groups of induction and maintenance drugs, the anesthesiologist carried out induction and intraoperative maintenance according to the plan, and sufentanil analgesia pump was prepared after the operation, and the research assistant gave the experimental analgesia pump at the same time. After the operation, they returned to the recovery room (PACU), and were evaluated by nurses in PACU, followed up by another research assistant. During the trial, only the research assistant who is dispensing drugs knows the grouping situation, and he/she will not participate in anesthesia and evaluation of patients at any time. Anesthesiologists, surgeons, postoperative follow-up nurses, patients and ward nurses all don't know the grouping situation.

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

万方数据库

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Wanfang database

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case record form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2024-04-18 08:10:46